ABSTRACT
Objective To assess the efficacy and safety of berberine, amoxicillin, lansoprazole, bismuth quadruple therapy for Helicobacter pylori (H.pylori)eradication.Methods From December 2015 to April 2016,566 patients with initial treatment of H.pylori infection were prospectively enrolled.Patients were divided into observation group (berberine, amoxicillin, lansoprazole, bismuth) and control group (clarithromycin, amoxicillin, lansoprazole, bismuth), 283 cases in each group, and the treatment courses in two groups were both 14 days.Four weeks after completion of the treatment, the eradication rate of H.pylori and adverse effect rate of the two groups were compared.Student t test and Chi square test were performed for comparison between the two groups.Results There was no statistically significant difference in the baseline demographic data including gender,age, body mass index (BMI), symptom score between patients of the two groups (all P>0.05).Four weeks after completion of the treatment, the eradication rates of observation group and control group were 87.5%(244/279) and 87.1%(242/278) according to per-protocol analysis, and which were 86.2%(244/283) and 85.5 %(242/283) according to intention-to-treat analysis.There was no statistically significant difference between the two groups (x2=0.021,0.058;both P>0.05).The adverse effect rates of the two groups were 12.5%(35/279) and 16.5%(46/278), and there was no statistically significant difference (x2=1.795,P=0.180).Conclusions Both the new quadruple regimen containing berberine, amoxicillin and bismuth, and the standard quadruple regimen containing clarithromycin, amoxicillin and bismuth both can effectively eradicate H.pylori infection.The new regimen might be recommended as first-line eradication regimen in Xi′an district or area with high clarithromycin resistance.